Patent application title: SOIL-BASED COMPOSITIONS AND METHODS FOR REMOVAL OF TOXINS FROM MAMMALS

Abstract:

Humans and other mammals are continually exposed to toxins in the
environment, toxins in ingested food and water, and toxins formed in the
body through metabolism or breakdown of complex material. Such toxins
impair health and contribute to disease in mammals but are difficult to
avoid given the conditions of modern life. The present invention provides
compositions for promoting removal of toxins from a subject which include
an alkalizing agent, spore-forming bacteria, clay, at least one type of
humic acid and/or at least one type of fulvic acid. Methods for use of
compositions for promoting removal of toxins from a subject are
described.

2. The method of claim 1, wherein the alkalizing agent is selected from
the group consisting of: a citric acid salt, a bicarbonate salt, dried
fruit, fresh fruit and a combination of any two or more of these.

3. The method of claim 2, wherein the citric acid salt is selected from
the group consisting of: calcium citrate, magnesium citrate, zinc
citrate, selenium citrate, manganese citrate, chromium citrate,
molybdenum citrate, potassium citrate, boron citrate and vanadium citrate
and a combination of any of two or more of these.

4. The method of claim 2, wherein the bicarbonate salt is selected from
the group consisting of: ammonia bicarbonate, calcium bicarbonate,
potassium bicarbonate, sodium bicarbonate and a combination of any of two
or more of these.

5. The method of claim 1, wherein the spore-forming bacteria are selected
from the group consisting of: B. subtilis, B. licheniformis, B. cereus,
B. megaterium, B. clausii, B. coagulans, B. laterosporus and a
combination of any of two or more of these.

6. The method of claim 1, wherein the spore-forming bacteria are selected
from the group consisting of: B. coagulans, B. laterosporus and a mixture
B. coagulans and B. laterosporus.

7. The method of claim 1, wherein the clay is a natural clay.

8. The method of claim 7, wherein the natural clay is a smectite clay.

9. The method of claim 8, wherein the smectite clay is selected from the
group consisting of: calcium bentonite, sodium bentonite and a mixture of
calcium bentonite and sodium bentonite.

10. The method of claim 1, further comprising intentionally electrically
grounding the subject for at least 1 hour-24 hours, inclusive, per day.

11. The method of claim 1, further comprising administering infrared
radiation having a wavelength in the range of about 5 microns-20 microns,
inclusive, to the subject for at least 1 hour-24 hours, inclusive, per
day.

12. The method of claim 1, further comprising administering infrared
radiation having a wavelength of about 10 microns to the subject for at
least 1 hour-24 hours, inclusive, per day.

14. The composition of claim 13, wherein the alkalizing agent is selected
from the group consisting of: a citric acid salt, a bicarbonate salt,
dried fruit, fresh fruit and a combination of any two or more of these.

15. The composition of claim 13, wherein the spore-forming bacteria are
selected from the group consisting of: B. subtilis, B. licheniformis, B.
cereus, B. megaterium, B. clausii, B. coagulans, B. laterosporus and a
combination of any of two or more of these.

16. The composition of claim 13, wherein the spore-forming bacteria are
selected from the group consisting of: B. coagulans, B. laterosporus and
a mixture B. coagulans and B. laterosporus.

17. The composition of claim 13, wherein the clay is a natural clay.

18. The composition of claim 17, wherein the natural clay is a smectite
clay.

19. The composition of claim 18, wherein the smectite clay is selected
from the group consisting of: calcium bentonite, sodium bentonite and a
mixture of calcium bentonite and sodium bentonite.

20. A method of producing a composition for promoting removal of toxins
from a subject, comprising:combining an alkalizing agent, isolated
spore-forming bacteria, isolated clay, and at least one isolated type of
humic acid and/or at least one isolated type of fulvic acid.

21. A method of inhibiting dandruff in a subject, comprising:administering
a therapeutically effective amount of a composition comprising isolated
spore-forming bacteria and/or an isolated soil component.

22. The method of claim 21, wherein the isolated soil component is at
least one type of humic acid and/or at least one type of fulvic acid.

23. The method of claim 21, wherein the composition further comprises a
pharmaceutically acceptable carrier, with the proviso that no lipids or
fatty acids are included in the carrier(s) or excipient(s).

24. The method of claim 23, wherein the pharmaceutically acceptable
carrier is clay.

[0002]The present invention relates generally to methods and compositions
for promoting health in a subject. The present invention relates
specifically to methods and compositions for promoting removal of toxins
from a subject.

BACKGROUND OF THE INVENTION

[0003]Humans and other mammals are continually exposed to toxins in the
environment, toxins in ingested food and water, and toxins formed in the
body through metabolism or breakdown of complex material. Such toxins
impair health and contribute to disease in mammals but are difficult to
avoid given the conditions of modern life.

SUMMARY OF TEE INVENTION

[0004]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which include
administering a therapeutically effective dose of a composition
comprising an alkalizing agent, spore-forming bacteria, clay, humic acid
and/or fulvic acid.

[0005]Alkalizing agents included can be one or more citric acid salts, one
or more bicarbonate salts, one or more dried fruits, one or more fresh
fruits or a combination of any two or more of these.

[0006]Spore-forming bacteria that can be included are illustratively B.
subtilis, B. licheniformis, B. cereus, B. megaterium, B. clausii, B.
coagulans, B. laterosporus or a combination of any of two or more of
these. In preferred embodiments, spore-forming bacteria included in
inventive compositions are B. coagulans, B. laterosporus or a combination
B. coagulans and B. laterosporus.

[0007]Clay included in embodiments of inventive compositions is a natural
clay, preferably a smectite clay. Optionally, the smectite clay is
calcium bentonite, sodium bentonite or both calcium bentonite and sodium
bentonite.

[0008]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which further include
intentionally electrically grounding the subject for at least 1 hour-24
hours, inclusive, per day.

[0009]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which further include
administering infrared radiation having a wavelength in the range of
about 5 microns-20 microns, inclusive, to the subject for at least 1
hour-24 hours, inclusive, per day. In preferred embodiments, the
administered infrared radiation has a wavelength of about 10 microns.

[0010]Compositions for promoting removal of toxins from a subject are
provided according to embodiments of the present invention which include
an alkalizing agent, spore-forming bacteria, clay, one or more humic
acids and/or one or more fulvic acids.

[0011]Methods of inhibiting dandruff in a subject are provided according
to embodiments of the present invention which include administering a
therapeutically effective amount of a composition comprising isolated
spore-forming bacteria and/or an isolated soil component. The isolated
soil component is at least one type of humic acid and/or at least one
type of fulvic acid in embodiments of inventive compositions and methods.

[0012]A pharmaceutically acceptable carrier can be included and optionally
the pharmaceutically acceptable carrier includes clay.

[0013]Compositions for inhibiting dandruff in a subject are provided
according to embodiments of the present invention which include isolated
spore-forming bacteria and/or an isolated soil component. A
pharmaceutically acceptable carrier can be included and optionally the
pharmaceutically acceptable carrier includes clay.

DETAILED DESCRIPTION OF THE INVENTION

[0014]Compositions and methods promoting removal of toxins from mammals
are provided according to the present invention. Further advantageous
effects of inventive compositions include stimulation of the immune
system of an animal, nutritive value, and antimicrobial activity.
Antimicrobial activity is direct, e.g. antibiotic producers, and/or
indirect, e.g. inhibition of undesirable microbes by competitive
exclusion.

[0015]Compositions for removal of toxins from mammals according to the
present invention are "soil-based" and include three soil components and
an alkalizing agent. Compositions of the present invention are believed
to provide a synergistic detoxification effect, the components more
effective in combination that the individual components alone.

[0017]The term "isolated" used herein refers to a component which is
substantially separated or produced apart from substances with which the
component naturally occurs. The term "isolated" does not implicate
absolute purity of the component but is intended as a relative term. In
preferred embodiments, the isolated component is at least 90% pure such
that the component represents at least 90% of a preparation of the
component used to make a composition of the present invention. In further
preferred embodiments, the isolated component is at least 95% or greater
pure such that the component represents at least 95% or greater of a
preparation of the component used to make a composition of the present
invention. Thus, for example, compositions according to embodiments of
the present invention are prepared by combining: isolated spore-forming
bacteria which is at least 90% pure, preferably at least 95% or greater
pure, isolated clay which is at least 90% pure, preferably at least 95%
or greater pure and isolated complex organic materials commonly found in
soil, namely one or more humic acids and/or one or more fulvic acids,
which are at least 90% pure, preferably at least 95% or greater pure.

[0018]Spore-forming bacteria included in compositions of the present
invention include bacilli and clostridia which are not mammalian
pathogens in dosage amounts used in the present invention. Such
spore-forming bacteria are described in detail in standard references
such as Bergey's Manual of Systematic Bacteriology, Springer-Verlag, 2nd
Ed. 2005. Bacteria can be obtained from any of various sources for
inclusion in an inventive composition, such as a commercial source, a
repository, such as the American Type Culture Collection (ATCC), or by
isolation from a natural source, such as soil. Methods for isolation and
identification of spore-forming bacteria are known in the art.

[0020]A preferred embodiment of a composition of the present invention
includes B. coagulans, and/or B. laterosporus.

[0021]Clay included in a composition of the present invention is
preferably a natural clay. Preferred natural clays are smectites,
particularly calcium bentonites and sodium bentonites illustratively
including, and not limited to, Pascalite, Terramin and Redmond clay.
Natural clays are obtained commercially or isolated from the natural
environment.

[0022]Clay included in an inventive composition is preferably in the form
of hydrated clay or dry powdered clay.

[0023]Humic acids and/or fulvic acids are included in compositions of the
present invention. Humic acids and fulvic acids are a subset of humic
substances, described in detail in references such as "Humus Chemistry:
Genesis, Composition, Reactions", F. J. Stevenson, John Wiley & Sons, New
York, 2nd Ed., 1994. Humic acids and fulvic acids are available
commercially and can be isolated from natural sources such as soil and
peat.

[0024]An alkalizing agent is included in compositions of the present
invention for promoting a pH neutral or alkaline environment in the body
of a mammal to which the composition is administered, as reflected by the
value of urine pH. In particular, the soil-based components of an
inventive composition, spore-forming bacteria, clay and humic and/or
fulvic acids are believed to be most active to bind and retain toxins,
and thereby promote removal of toxins from a mammalian body, in a neutral
or alkaline environment.

[0026]Bicarbonates are another alkalizing agent optionally included in
inventive compositions. In particular, ammonia, calcium, potassium and/or
sodium bicarbonate can be included.

[0027]Fruit is an alkalizing agent included in compositions of the present
invention. Fruit is included in any form suitable for promoting an
alkaline environment in a mammalian body, including but not limited to
dried fruit and fresh fruit.

[0028]Methods of producing a composition for promoting removal of toxins
from a subject are provided according to embodiments of the present
invention which include combining an alkalizing agent, one or more types
of isolated spore-forming bacteria, isolated clay, and at least one
isolated type of humic acid and/or at least one isolated type of fulvic
acid.

[0029]Amounts of the individual components in a composition of the present
invention are each independently in the range of about 0.1-99% by weight
of the total composition. One or more pharmaceutically acceptable
carriers or excipients are optionally included in the composition.

[0030]In a particular embodiment, a composition of the present invention
is administered contained in an ingestible capsule for oral ingestion.
Capsule formulation is optionally designed to target release of the
contained composition of the present invention to a particular target
region, such as the stomach, small intestine and/or or large intestine.

[0032]Methods of the present invention include administration of a
composition including three soil components and an alkalizing agent
substantially as described herein to a mammalian subject in order to
promote removal of toxins from the subject.

[0033]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which include
administering a therapeutically effective amount of a composition of the
present invention.

[0034]The term "therapeutically effective amount" refers to an amount that
elicits a desired therapeutic effect or provides a desired benefit. A
preferred therapeutically effective amount is an amount which promotes
removal of toxins from the subject. A further preferred therapeutically
effective amount stimulates the immune system of the subject, provides
nutritive value and provides antimicrobial activity. A further preferred
therapeutically effective amount causes the subject to produce urine in a
pH neutral or alkaline state. Therapeutically effective amounts and
therapeutic effects of compositions and methods of the present invention
can be assessed using any of various assays known to one of skill in the
art.

[0035]Administration can include a single dose or multiple doses. Multiple
doses are optionally administered each day and/or over the course of
several days-weeks. In a further option, multiple doses are administered
over a longer period, such as weeks-years, or indefinitely.

[0036]Exemplary non-limiting dosage ranges are described below.

[0037]Spore forming bacteria are administered in amounts of about
104-1012 colony forming units (CFU)/dose. Typically about 1 to
20 doses per day are administered.

[0038]Clay is administered in amounts of about 100 mg-1 gram/dose and
about 1-60 grams per day are administered.

[0039]Humic acids and/or fulvic acids are administered in amounts of about
50 mg to 1 gram per dose. Typically, about 1 to 6 doses per day are
administered.

[0040]An alkalizing agent is administered in an amount effective to
maintain the urine produced by the subject in a pH neutral or alkaline
state. Thus, in a subject treated with a composition of the present
invention, the pH of urine can be monitored one or more times each day.
Additional doses or a dosage form with more alkalizing agent is
administered as necessary so that the subject produces urine in a pH
neutral or alkaline state.

[0041]Any effective amount of an alkalizing agent can be included in a
composition of the present invention.

[0042]For example, a citrate-based alkalizing agent can be administered in
amounts of about 0.1 g-10 g/dose. Typically about 1 to 10 doses per day
are administered.

[0044]In a further example, 4-8 g of potassium citrate is administered per
day in a single dose or divided among multiple doses.

[0045]Exemplary doses of bicarbonate include but are not limited to 1-300
mEq. Typically about 1 to 10 doses per day are administered.

[0046]Fruit is also optionally included in compositions and administered
in amounts effective to maintain the urine produced by the subject in a
pH neutral or alkaline state. Many fruits contain citrates and are
administered in amounts sufficient to deliver a citrate-based alkalizing
agent in amounts of about 0.1 g-10 g/dose. Typically about 1 to 10 doses
per day are administered.

[0047]Compositions for promoting removal of toxins from a subject are
formed by combining active ingredients which can each individually be in
solid, liquid or semi-liquid form.

[0048]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which further include
electrically grounding the subject for at least 1-24 hours/day.

[0049]Until relatively recently, human beings walked barefoot and slept
directly on the earth, which is electrically neutral. In the last few
decades, however, the use of shoes having non-conductive soles, synthetic
carpeting and other floor materials have insulated people and animals
from the earth. Studies have shown that earth grounding is an important
source of free radicals which function as natural antioxidants. It is
believed that the build-up of electrical charge in a human body may have
detrimental side-effects. Research has indicated that stored charge may
interfere with normal cellular communications and the self-regulating and
self-healing mechanisms of the body, which in turn may create stress and
lead to certain maladies. In particular, electrostatic charge build-up
may adversely affect the nervous system, causing muscle stiffness and
back pain. In this physiologically stressed state, blood pressure rises,
heart rate increases, and the digestive process slows. It is believed
that the unnatural presence of electrostatic charges on the body may also
have a correlation with certain diseases, at least partly because
electrical isolation interferes with normal immune system function and
increases inflammation.

[0050]Electrical grounding of a subject is achieved, for instance, using
an apparatus that includes an electrically conductive element having a
first end connected to an electrical ground and a second end in contact
with the subject directly or indirectly, such as by connection to an
electrically conductive element of an object connected to the electrical
ground. Such objects are preferably articles that the subject contacts
frequently or for extended periods of time such that the subject is
intentionally electrically grounded for at least 1-24 hours/day. Such
objects illustratively include an electrically conductive portion of a
computer mouse or keyboard, an electrically conductive portion of an
article of furniture such as a chair or bed, an electrically conductive
portion of a housing for an animal or an electrically conductive portion
of a member within the housing such as an electrically conductive perch,
an electrically conductive food or water bowl, an electrically conductive
sleeping pad, or an electrically conductive food or water bowl.

[0051]Electrical grounding apparatus for use in methods according to
embodiments of the present invention can include existing devices
modified to electrically ground a user and/or use of methods and/or
devices disclosed in U.S. Pat. Nos. 6,683,779; 7,212,392 and U.S.
Application Publication Nos. 2006/0285266 and 20080022941.

[0052]Methods of promoting removal of toxins from a subject are provided
according to embodiments of the present invention which further include
exposing the subject to Far Infrared radiation for at least 1-24
hours/day.

[0053]Far infrared radiation, having a wavelength of about 5-20 microns,
inclusive, preferably having a wavelength of about 10 microns, is
administered to heat at least portions of the body of a subject according
to embodiments of inventive methods. Methods of the present invention
preferably include administration of far infrared radiation to a subject
using a far infrared heater or heating pad. The infrared heater produces
radiant energy, which is the same as the heat from the sun, only without
the harmful ultraviolet rays. The radiation penetrates the body and heats
through a process called conversion, instead of heating the air around
the user.

[0054]It is believed that administered far infrared heat penetrates more
than 1.5 inches (40 mm) into the body. The argument is based on the idea
that the wavelengths of far infrared waves are typically between 5.8 and
1000 micrometers. This is supposed to correspond to the vibration of the
water molecule at 9.4 micrometers. Because these vibrations are similar,
the infrared rays help release toxins from fat cells and other cells, and
the toxins can be released through sweating or other mechanisms of bodily
elimination. Far infrared radiation is directed to any area for which a
therapeutic effect is desired, illustratively including whole body,
kidneys, sinuses and intestines.

[0055]A subject treated according to a method of the present invention can
be any mammal, including human and non-human primates, cats, dogs,
horses, sheep, goats, cattle, pigs, rabbits, and rodents. In preferred
embodiments, the subject is human.

[0056]Compositions and methods are provided according to the present
invention for inhibiting Melassezia fungal infection of the scalp which
causes dandruff in an affected subject.

[0057]Malassezia fungi require exogenously supplied lipids since these
organisms are incapable of producing metabolically required fatty acids.
As a consequence, Malassezia fungi are frequently found associated with
sebaceous glands on the scalp, causing dandruff.

[0058]Methods of treating a subject to inhibit dandruff include
administering a composition including a therapeutically effective amount
of isolated spore-forming bacteria and/or an isolated soil component
which is at least one type of humic acid and/or at least one type of
fulvic acid.

[0059]One or more pharmaceutically acceptable carriers or excipients are
optionally included in the composition for inhibiting dandruff, with the
proviso that no lipids or fatty acids are included in the carrier(s) or
excipient(s) since these substances enhance Malassezia fungi growth.
Conventional pharmaceutically acceptable carriers or excipients typically
used in formulations for application to the scalp or skin of a subject
can be used with the proviso that no lipids or fatty acids are included
in the carrier(s) or excipient(s).

[0060]In embodiments of the present invention, clay is a pharmaceutically
acceptable carrier included in a composition for inhibiting dandruff
including a therapeutically effective amount of isolated spore-forming
bacteria and/or an isolated soil component which is at least one type of
humic acid and/or at least one type of fulvic acid.

[0061]The spore-forming bacteria and/or the soil component are each
individually present in a composition for treating a subject to inhibit
dandruff in an amount in the range of 1% weight/total weight of the
composition-99% or greater weight/total weight of the composition or up
to saturation of the carrier.

[0062]The term "pharmaceutically acceptable carrier" refers to an organic,
inorganic, liquid, or solid, natural or synthetic substance suitable for
administration to a subject which is combined with an active ingredient
to facilitate administration and which is compatible with the active
ingredient(s) such that the carrier does not substantially impair the
desired therapeutic effect of the active ingredient(s).

[0063]The following references contain information relevant to the present
application and are hereby incorporated by reference in their entirety
for all purposes.

[0077]Any patents or publications mentioned in this specification are
incorporated herein by reference to the same extent as if each individual
publication is specifically and individually indicated to be incorporated
by reference.

[0078]The compositions and methods described herein are presently
representative of preferred embodiments, exemplary, and not intended as
limitations on the scope of the invention. Changes therein and other uses
will occur to those skilled in the art.